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Biotech Stock Mailbag: Celsion

Harold J. emails, "Could you be persuaded to write an article giving the three or four biotechs with drugs in phase III that you think have the best chance to be approved in the near future by the FDA? I am thinking specifically of Incyte, Exelixis, Seattle Genetics and ??? Thanks. Perhaps, also NPS Pharmaceuticals.

Let's go through your list:

Incyte (INCY - Get Report): Ruxolitinib, the JAK inhibitor partnered with Novartis (NVS) for myelofibrosis, has a good chance of receiving U.S. and European approval based on positive results from two phase III studies. Incyte and Novartis are expected to complete the Ruxo approval submissions this quarter, which should lead to approval by the end of the year. One important note: Pay attention to next month's American Society of Clinical Oncology (ASCO) annual meeting, where the detailed data from the two Ruxo phase III studies will be presented.

Exelixis (EXEL): Too early to make an approval prediction about cabozantinib. Results from the phase III study in medullary thyroid cancer are expected midyear, while phase III studies in prostate cancer haven't started.

Seattle Genetics (SGEN): Yes, Adcetris (hate the name) will receive FDA approval for relapsed/refractory Hodgkin lymphoma and relapsed/refractory systemic anaplastic large cell lymphoma (ALCL). The FDA approval decision date is Aug. 30.

NPS Pharmaceuticals (NPSP): Gattex for the treatment of short bowel syndrome. Yes, I like the drug's approval chances.

More biotech stocks for the "best chance for approval" bucket: Vertex Pharmaceuticals (VRTX), Optimer Pharmaceuticals (OPTR), Amarin (AMRN), and Onyx Pharmaceuticals (ONXX).

Which drugs are a toss-up (less-than-good chance) for near-term approval? The Zelrix migraine patch from Nupath (PATH); the abuse-resistant painkiller Acurox from Pfizer (PFE) and Acura Pharma (ACUR); the abuse-resistant painkiller Remoxy from Pfizer and Pain Therapeutics (PTIE); and the insomnia drug Intermezzo from Transcept Pharma (TSPT).

Back to Twitter. @quickgainstocks asks, "Outlook on $OXGN?"

I don't know for sure what caused Oxigene (OXGN) shares to fly this week. I doubt the surge has much to do with the company's fundamentals or significant changes to the outlook for the cancer drugs in its pipeline. This move looks more like a quirky trading phenomenon related to a penny biotech stock with a tiny float, magnified by speculative bets ahead of next week's release of research abstract for the ASCO annual meeting.

Researchers at the ASCO meeting will be presenting updates on two studies of Oxigene's experimental cancer drug Zybrestat:

Final data, including a final survival analysis, will be presented from the "FACT" phase II/III study of Zybrestat in patients with anaplastic thyroid cancer (ATC).
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OPTR $0.00 0.00%
CLSN $1.51 -2.60%
DCTH $0.29 -9.30%
EXEL $4.33 -7.28%
INCY $68.62 -4.80%


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